Quantiferon for Detection of Latent Tuberculosis in Healthcare Workers

Phase 4

Completed

• Conditions: Tuberculosis
• Interventions: Procedure: Quantiferon Gold

• Registration Number: NCT00797836
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The accuracy of tuberculin skin test (TST) for detecting latent tuberculosis is limited in countries with a high proportion of population having received vaccination with the BCG. We aim to determine the cost-effectiveness of Quantiferon gold (QTFG), compared to BCG vaccine to detect latent tuberculosis in exposed healthcare workers (HCWs)

Detailed Description

The QUANTIPS study includes two components:

1. survey of HCWs working in high-risk units (respiratory diseases or infectious diseases with at least 5 case of smear-positive pulmonary tuberculosis par year) from 14 University hospitals in France

2. Follow-up of HCWs with unexpected exposure to a patient with contagious tuberculosis (delay in respiratory isolation of a smear-positive patient) in 4 University hospitals Main objective: Therapeutic impact of tuberculosis screening using TST compared to QFTG. The impact is defined by the decision to treat of not a HCW with latent tuberculosis using QFTG, compared to the decision which would have been based on TST alone

Secondary objectives:

* Cost-effectiveness of replacing TST by QFTG

* Prevalence and incidence of latent tuberculosis in exposed HCWs (Part 1)

* Incidence of latent tuberculosis in HCWs exposed to an index case (part 2) Inclusion: HCWs who volunteer to participate in units with at least 5 patients with smear-positive tuberculosis each year (Group 1), HCWs exposed to a smear-positive patient non isolated at hospital admission (Group 2) Study population: 2000 (Group 1) and 600 (Group 2) HCWs Study duration: inclusion during 3 months, follow-up of one year (Group 1 ); Inclusion for one year, with a 3-month follow up (Group 2)

Study exams:

* Group 1 : TST, QFTG, chest radiography at baseline and after one year

* Group 2 : TST, QFTG, chest radiography at baseline (within 3 weeks after exposure) and after 3 months

Endpoints:

* therapeutic decision regarding tuberculosis treatment, with a cost-effectiveness analysis (Markov's modelling)

* prevalence and incidence of latent tuberculosis

Study Timeline

• Status Verified: 2008-11
• Study Start: 2008-11
• Study First Submitted: 2008-11-24
• Study First Submitted QC: 2008-11-24
• Study First Posted: 2008-11-25
• Primary Completion: 2010-10
• Study Completion: 2010-11
• Last Update Submitted: 2012-01-09
• Last Update Posted: 2012-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1024

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Quantiferon Gold	Quantiferon Gold	-

Primary Outcome Measures

Name	Time	Method
Therapeutic impact of tuberculosis screening using QFTG compared to TST. The impact is defined by the decision to treat of not a HCW with latent tuberculosis using QFTG, compared to the decision which would have been based on TST alone	18 months

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness of replacing TST by QFTG	18 months
Prevalence and incidence of latent tuberculosis in exposed HCWs (Group 1)	18 months
Incidence of latent tuberculosis in HCWs exposed to an index case (Group 2)	18 months

Trial Locations

Locations (1)

CHU Bichat Claude Bernard; 🇫🇷 Paris, Ile de France, France